MSCs For Treatment of Azoospermic Patients
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients|
- All Cases Improvement [ Time Frame: One Year (12-Month) ] [ Designated as safety issue: Yes ]Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potencey.
- All Cases Fertility Improvement [ Time Frame: One Year (12-Month) ] [ Designated as safety issue: Yes ]Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potencey.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Laboratory and Clinical
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis.
Biological: Stem Cells
60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02025270
|Contact: Taimour M Khalifa, MDfirstname.lastname@example.org|
|Contact: Sayed Bakry, PhDemail@example.com|
|Al Azhar University , School of Medicine||Recruiting|
|Nasr City, Cairo, Egypt, 11884|
|Contact: Sayed Bakry, PhD +201006609978 firstname.lastname@example.org|
|Principal Investigator: Taimour Khalifa, MD|
|Sub-Investigator: Sayed Bakry, PhD|
|Sub-Investigator: Hala Gabr, MD|
|Sub-Investigator: Wael Abu El Khier, MD|
|Principal Investigator:||Taimour M Khalifa, MD Professor||Al-Azhar University|
|Study Director:||Sayed Bakry, PhD||Al-Azhar University|
|Study Chair:||Hala Gabr, MD||Cairo University|
|Study Chair:||Wael Abu Elkhier, MD||Miltary Academy|
|Study Chair:||Saad Moneer, MSc||Al-Azhar University|
|Study Chair:||Yasser Aly Elsheikh, MD||Chairman of Urology & Andrology Department- Al Galaa Military Complex|
|Study Chair:||Ahmed Kadeh, MSc||Al-Azhar University|